Prescription drug · NDA AUTHORIZED GENERIC
Atovaquone and Proguanil HCl (Atovaquone and proguanil hydrochloride) NDC 50090-2980
Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2980-0 | 5009029800050090298000 | 7 TABLET, FILM COATED in 1 BOTTLE (50090-2980-0)Marketed from May 4, 2017 | |
| 50090-2980-1 | 5009029800150090298001 | 12 TABLET, FILM COATED in 1 BOTTLE (50090-2980-1)Marketed from Apr 27, 2017 | |
| 50090-2980-2 | 5009029800250090298002 | 14 TABLET, FILM COATED in 1 BOTTLE (50090-2980-2)Marketed from May 8, 2017 | |
| 50090-2980-3 | 5009029800350090298003 | 16 TABLET, FILM COATED in 1 BOTTLE (50090-2980-3)Marketed from Apr 28, 2017 | |
| 50090-2980-4 | 5009029800450090298004 | 24 TABLET, FILM COATED in 1 BOTTLE (50090-2980-4)Marketed from Apr 21, 2017 | |
| 50090-2980-5 | 5009029800550090298005 | 5 TABLET, FILM COATED in 1 BOTTLE (50090-2980-5)Marketed from Apr 25, 2017 | |
| 50090-2980-6 | 5009029800650090298006 | 10 TABLET, FILM COATED in 1 BOTTLE (50090-2980-6)Marketed from Nov 16, 2017 | |
| 50090-2980-7 | 5009029800750090298007 | 100 TABLET, FILM COATED in 1 BOTTLE (50090-2980-7)Marketed from Jan 17, 2018 | |
| 50090-2980-8 | 5009029800850090298008 | 20 TABLET, FILM COATED in 1 BOTTLE (50090-2980-8)Marketed from Feb 1, 2018 | |
| 50090-2980-9 | 5009029800950090298009 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2980-9)Marketed from Feb 12, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Atovaquone and Proguanil HCl
- Generic name (nonproprietary)
- atovaquone and proguanil hydrochloride
- Active ingredients
- Atovaquone — 250 mg/1Proguanil hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021078
- Marketing start
- Listing expires
- Other FDA classes
- Dihydrofolate Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-2980_db61f577-1818-4643-8712-23db5c162ae6SPL ID db61f577-1818-4643-8712-23db5c162ae6SPL set ID 593baf3d-bd9e-4a44-8f90-125aa4a7a99eRxCUI 864675UNII Y883P1Z2LT, R71Y86M0WT
- Pharmacologic class
- Antimalarial; Antiprotozoal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090298000followed by a unit qualifier and the quantityPackage 50090-2980-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Atovaquone and Proguanil Hydrochloride tablets are an antimalarial indicated for: • prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. ( 1.1 ) • treatment of acute, uncomplicated P. falciparum malaria. ( 1.2 ) 1.1 Prevention of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the prophylaxis of Plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. 1.2 Treatment of Malaria Atovaquone and Proguanil Hydrochloride tablets are indicated for the treatment of acute, uncomplicated P. falciparum malaria. Atovaquone and proguanil hydrochloride have been shown to be effectiv…
Excerpt only. Read the full label for complete information.
About NDC 50090-2980
- What is NDC 50090-2980?
- 50090-2980 is the product NDC for Atovaquone and Proguanil HCl, Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 10 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atovaquone and Proguanil HCl (Atovaquone and proguanil hydrochloride).
- What is the active ingredient?
- Atovaquone, Proguanil hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atovaquone and Proguanil HCl?
- 1 other product NDC are listed under this name. See all Atovaquone and Proguanil HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atovaquone and Proguanil HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-060 | 66993-0060-0266993-0060-27 |
Other NDCs under NDA 021078
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Atovaquone and Proguanil HClatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | Prasco Laboratories | 66993-060 |
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 250 mg/1; Proguanil hydrochloride 100 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0675 |
| Malaroneatovaquone and proguanil hydrochloride | Atovaquone 62.5 mg/1; Proguanil hydrochloride 25 mg/1 | Tablet, Film coatedOral | GlaxoSmithKline LLC | 0173-0676 |